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November 2020
Issue Summary:
This month we return to focus on the impacts of the COVID-19 pandemic. To being with, our feature article focuses on the efforts of the FDA, FTC, and DOJ to combat fraudulent products claiming to prevent, treat, or ameliorate the effects of COVID-19. Next, we look at how the DOJ plans to use the False Claims Act to address pandemic-related fraud.
On the Litigation front, we examine the recent Sun Pharmaceuticals settlement and CIA. In this article we compare Sun’s situation with those of Indivior and Novartis before it.
Turning to Governance and Operations, John Auerbach, Michael Jelen and Jenny McVey in the final installment of our Tele-Compliance series examine the digital developments impacting case management. Finally, we round out this month with an article by Ben Schein on how to avoid mistakes in during post-acquisition audits and integration activities.
Where There is Money, There is Fraud
Where There is Money, There is Fraud
By Gwendolyn A. Ball, Staff Writer
Summary: With the pandemic, the number of bogus and unproven products for COVID-19 has grown exponentially. At the same, although not widely reported, the FDA, FTC, and DOJ have stepped up enforcement actions against the sellers of these products to maintain public confidence. This article examines the efforts of those agencies to hold the line against unscrupulous individuals and companies.
Shaped by the Pandemic
The Justice Department Reasserts Compliance Authority under the False Claims Act
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: In June 2020, the United States Department of Justice outlined its efforts to reassert its compliance authority under the Federal False Claim Act in the context of the current pandemic. Not surprisingly, the DOJ clearly will continue to play a significant role in terms of FCA enforcement.
Product Promotion Continues to Vex Drug Companies
The Sun Pharmaceutical Settlement & CIA Mirror Issues Previously Seen
By Kaitlin Fallon Wildoner, Esq., Staff Writer
Summary: The recent Sun Pharmaceutical settlement and CIA mirror elements and issues seen in both the Indivior and Novartis cases. This article details the latest settlement with Sun and examine them in light of those previous two cases.
The Tele-Compliance Ecosystem (Part 4)
Virtual Case Management
By: John Auerbach and Michael Jelen with contributions from Jenny McVey, Ph.D.
Summary: Over the past few months, we have discussed how the COVID-19 pandemic has highlighted the urgency of incorporating remote and digital capabilities into current compliance programs. We noted that what we call a tele-compliance capability requires a comprehensive re-thinking of how data, process, people, and tools work together to improve compliance effectiveness. This article concludes the series by turning the tele-compliance transformation focus on the challenge of Compliance Case Management.
The Art of the Post-Acquisition Compliance Audit
How to Avoid Mistakes, Frustrations & Delays
ByBen Schein, Staff Writer
Summary: The “best practices” guidance provided by regulators has tremendous value when developing a strategy for implementing and expanding a compliance program within in a newly acquired organization. However, it is incumbent on compliance leaders to tailor that guidance to the unique context at hand in order to achieve real effectiveness. This article provides seven practical tips to avoid mistakes, frustrations, and delays when taking on the task of post-acquisition due diligence.
Widening the Net
New Price Fixing Complaint Includes Both Companies and Individuals
By Kirt Kraeuter, Staff Writer
Summary: The U.S. Department of Justice and States Attorneys General investigation into price-fixing by generic pharmaceutical companies and their executives continues to sweep in more corporate and individual defendants. The most recent civil complaint, with Sandoz as primary defendant, provides substantial evidence to support widening the investigative net.
The DEA, Plaintiffs’ Counsel & Now Shareholders
McKesson’s Opioid Woes Continue
By Robert N. Wilkey, Senior Staff Writer
Summary: On April 10, 2020, United States District Judge Claudia Wilken, for the Northern District of California, entered an order, approving the settlement of a derivative lawsuit against the McKesson Corporation (“McKesson”). The lawsuit alleged that McKesson’s Board of Directors and senior executives failed to monitor and oversee the company’s operations concerning its distribution of controlled substances. The significance of this settlement is how shareholder derivative litigation supports internal compliance efforts, and it serves as a template for future similar actions.